The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
- Company
- Circulatory Technology Inc
- Recall Initiated
- July 1, 2016
- Terminated
- June 14, 2018
- Recall Number
- Z-2832-2016
- Quantity
- 20 units
- Firm Location
- Oyster Bay, NY
Reason for Recall
The seal between the balloon and the housing may leak.
Distribution
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Lot / Code Info
Lot # 014648 USE BY: 09/01/2018
Root Cause
Device Design
Action Taken
The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to ytamari@cirtec.com. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.
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